MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MOUTHPIECE

Model Number MAJ-674

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the customer found the white solids attached to the sterilization bag and beige-colored powder adhered to the body of mouthpiece.The mouthpiece was still brand-new and the event occurred after autoclaving prior to the first use.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and correct the h6 "method" in the previous report.Two mouthpieces and the sterilization bag in this report were returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that the returned mouthpieces and sterilization bag had foreign material on them.The exact cause of the reported event such as when and how the foreign material adhered to the mouthpiece and sterilization bag could not be conclusively determined.However, omsc concluded that the attached foreign material may be derived from sponge, etc., because the main component of the foreign material is melamine as a result of component analysis.If additional information becomes available, this report will be supplemented.

• Brand Name: MOUTHPIECE
• Type of Device: MOUTHPIECE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10957502
• MDR Text Key: 219974359
• Report Number: 8010047-2020-09927
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-674
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1